JA0005

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

Brief summary

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Medical Condition

Enthesitis-related arthritis

Min. Age

2
Years

Max. Age

18
Years

Who Can Join?

All

Status

Recruiting
Inclusion criteria
- Study participant must be 2 to <18 years of age inclusive, at the Baseline Visit. - Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 6 months duration prior to the Screening Visit. - Study participants who have active disease (ERA [including JAS] and/or JPsA) defined as having at least 3 active joints and for ERA at least 1 site of enthesitis at Baseline or documented by history. - Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID). - Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.) - Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs with the exception of methotrexate or sulfasalazine. - Body weight of ≥10kg. - Male and female. - A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period) - Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol.
Exclusion criteria
- Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA). - Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD. - Study participant has active uncontrolled uveitis. - Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated. - Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study. - Study participant has laboratory abnormalities at Screening defined in the Protocol. - Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections). - Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments. - Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier. - Study participant had prior treatment with more than one biologic response modifier (other than an IL-17). - Presence of active suicidal ideation, or positive suicide behavior. - Study participant has been diagnosed with severe depression in the past 6 months.

Study Medication Description

Study Medication:

Bimzelx

Other Descriptive Name:

bimekizumab

Placebo

No

Comparator:

No

Study Dates

March 2025

Actual Start Date of Enrollment

June 2030

Planned Study Completion Date

General Information

Study ID:
JA0005
CT.gov Number:
NCT06668181
Phase:
Phase 3

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